BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190441 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41121
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO CORRODED BATTERY TUBE. UNABLE TO VERIFY BATTERY OUT LIMIT ALARM, BUTTON ERROR ALARM OR NO BUTTON RESPONSE DUE TO BLANK DISPLAY. HOWEVER FOUND CORRODED KEYPAD TRACES DURING VISUAL INSPECTION. THE INSULIN PUMP HAS STRIPPED BATTERY COIN SLOT, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. CUSTOMER'S MOTHER ATTEMPTED TO CLEAR THE ALARM AND IT WOULDN'T CLEAR. CUSTOMER'S MOTHER STATED THEY PUT IN A NEW BATTERY AND THE DEVICE ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 198 MG/DL. ALARM AND POSSIBLE CAUSE WERE EXPLAINED TO CUSTOMER'S MOTHER. CUSTOMER'S MOTHER DOES NOT RECALL ANY SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE KEYPAD ISSUE. SHE STATED CUSTOMER WAS AT A FRIEND'S HOUSE AND CUSTOMER CALLED HER STATING THE DEVICE WAS BROKEN. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667781 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR